Sunscreen Spf 30 Spray
FDA Label NDC 49757-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rocky Mountain for the product Sunscreen Spf 30 (NDC 49757-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding avobenzone 3% ........................................................ sunscreen homosalate 10% ...................................................... sunscreen octisalate 5% ............................................................sunscreen, uses, warnings:, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Avobenzone 3% ........................................................ Sunscreen Homosalate 10% ...................................................... Sunscreen Octisalate 5% ............................................................Sunscreen

Uses

■ helps prevent sunburn ■ if used as directed with other sun
protection measures (see Directions), decreases the risk of skin
cancer and early skin aging caused by the sun.

Warnings:

For external use only

Flammable:Do not use white smoking or near heat or flame.

Do not useon damaged or broken skin.
When using this product■ keep out of eyes. Rinse eyes with water
to remove.
Stop use and ask a doctor ifrash occurs.

Keep Out Of Reach Of Children.

Iswallowed, get medical help or contact a Polson Control Center right away.

Directions

 ■ apply liberally 15 minutes before sun exposure.
Reapply: ■ after 80 minutes of swimming or sweating ■ Immediately
after towel drying ■ at least every 2 hours. Sun protection
measures:Spending time In the sun Increases your risk of skin
cancer and early skin aging. To decrease risk, regularly use a
sunscreen with broad spectrum SPF of 15 or higher and other sun
protection measures lncludlng: ■ limit time In the sun, especlally
from 10am to 2pm ■ wear long-sleeved shirts, pants, hats, and
sunglasses ■ children under 6 months: ask a doctor ■ do not spray
directly Into face. Spray on hands then apply to face ■ use In
well-ventilated area.

Other Information

protect this product from excessive
heat and direct sun ■ may stain fabrics.

Inactive Ingredients

Butyloctyi Sallcylate, Ethyl Alcohol
Denatured, Polyester-8, Oryza Sativa (Rice Bran) Oil, VA/Butyl
Maleate/lsobomyl Acrylate Copolymer.

* Please review the disclaimer below.